Cleared Traditional

K860097 - THERAPEUTIC DRUG (TDM) CALIBRATOR

K860097 is an FDA 510(k) clearance for THERAPEUTIC DRUG (TDM) CALIBRATOR, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K860097 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
32d
Days
Class 1
Risk

K860097 is an FDA 510(k) clearance for the THERAPEUTIC DRUG (TDM) CALIBRATOR. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K860097

510(k) Number K860097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date February 11, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 171
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K860097.
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · Bio-Rad · Aug 1986
V-TREND QC TDM CONTROL SERUM 1,2,3.
K862817 · Texas Immunology, Inc. · Aug 1986
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919 · Fisher Scientific Co., LLC · Apr 1986
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · Quantimetrix Corp. · Oct 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · Bio-Rad · Jul 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945 · Syva Co. · Jan 1985